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Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dutasteride
Abiraterone
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histological or cytological evidence of adenocarcinoma of the prostate Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study. Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3). Minimum PSA must be ≥1.0 ng/dL. Age 18 years of age or older. ECOG performance status 0 or 1. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L platelets ≥ 100 × 10^9/L hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome serum albumin ≥ 30 g/L (3.0 g/dL) Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies: Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. Voluntary written consent prior to the performance of any research related activit Exclusion Criteria: Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride). Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    1245c positive (1245c+) patients with dutasteride

    1245c positive (1245c+) patients

    1245c negative (1245c-) patients

    Arm Description

    Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented

    Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented

    abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented

    Outcomes

    Primary Outcome Measures

    Number of patients with radiographic progression free survival (rPFS) rate
    Count the the number of patients with radiographic progression free survival (rPFS)

    Secondary Outcome Measures

    Determine overall survival (OS)
    The Kaplan-Meier product-limit estimator will be used to estimate OS distribution
    Number of patients with a PSA decline of ≥ 50%
    Count the number of patients with serologic progression. It is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases confirmed at least 2 weeks apart.

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    February 23, 2023
    Sponsor
    Masonic Cancer Center, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05705700
    Brief Title
    Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)
    Official Title
    Biomarker Study Targeting Abiraterone Metabolites and Polymporphisms in Men With PSA Progression on Abiraterone for the Treatment of Castration Resistant or Castration Sensitive Prostate Cancer (The Bio-STAMP Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Feasibility
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    January 2030 (Anticipated)
    Study Completion Date
    January 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masonic Cancer Center, University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1245c positive (1245c+) patients with dutasteride
    Arm Type
    Experimental
    Arm Description
    Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented
    Arm Title
    1245c positive (1245c+) patients
    Arm Type
    Experimental
    Arm Description
    Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented
    Arm Title
    1245c negative (1245c-) patients
    Arm Type
    Experimental
    Arm Description
    abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented
    Intervention Type
    Drug
    Intervention Name(s)
    Dutasteride
    Other Intervention Name(s)
    Abiraterone
    Intervention Description
    High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression
    Intervention Type
    Drug
    Intervention Name(s)
    Abiraterone
    Other Intervention Name(s)
    Dutasteride
    Intervention Description
    1000 mg PO daily
    Primary Outcome Measure Information:
    Title
    Number of patients with radiographic progression free survival (rPFS) rate
    Description
    Count the the number of patients with radiographic progression free survival (rPFS)
    Time Frame
    24 Weeks after study treatment
    Secondary Outcome Measure Information:
    Title
    Determine overall survival (OS)
    Description
    The Kaplan-Meier product-limit estimator will be used to estimate OS distribution
    Time Frame
    24 months from start of treatment assignment
    Title
    Number of patients with a PSA decline of ≥ 50%
    Description
    Count the number of patients with serologic progression. It is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases confirmed at least 2 weeks apart.
    Time Frame
    24 weeks of adding of adding high-dose dutasteride

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histological or cytological evidence of adenocarcinoma of the prostate Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study. Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3). Minimum PSA must be ≥1.0 ng/dL. Age 18 years of age or older. ECOG performance status 0 or 1. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L platelets ≥ 100 × 10^9/L hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome serum albumin ≥ 30 g/L (3.0 g/dL) Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies: Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. Voluntary written consent prior to the performance of any research related activit Exclusion Criteria: Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride). Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Ryan, MD
    Organizational Affiliation
    Masonic Cancer Center, Univeristy of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

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